NCT05305469

Brief Summary

This study aims to integrate multi-omics data and clinical indicators to reveal pathogen-specific molecular patterns in patients with sepsis and establish prognostic prediction models through multiple machine learning algorithms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

March 22, 2022

Last Update Submit

January 22, 2024

Conditions

Keywords

PrognosisInflammationImmuneMultiomicsMachine learning

Outcome Measures

Primary Outcomes (1)

  • Pathogen-specific patterns

    To elucidate the unique infection pathogen-specific molecular patterns in septic patients

    March 2022 - December 2023

Secondary Outcomes (1)

  • Prognostic prediction models

    March 2022 - December 2024

Study Arms (5)

GN

Gram-negative bacteria infection group

GP

Gram-positive bacteria infection group

Fungal

Fungal infection group

Viral

Viral infection group

Control

Non-sepsis group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study cases are from the Department of Critical Care Medicine, a top-grade hospital in Yantai

You may qualify if:

  • Patients with sepsis or septic shock who meet the diagnostic criteria (2016 sepsis 3.0 standard);
  • Age 18~85 years old.

You may not qualify if:

  • ICU stay of the subjects less than 72 hours;
  • Female subjects who are pregnant;
  • The subjects not sure if infected;
  • The subjects performed CPR;
  • The subjects suffer from chronic renal disease;
  • The subjects with incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

RECRUITING

Related Publications (1)

  • Wang J, Sun Y, Teng S, Li K. Prediction of sepsis mortality using metabolite biomarkers in the blood: a meta-analysis of death-related pathways and prospective validation. BMC Med. 2020 Apr 15;18(1):83. doi: 10.1186/s12916-020-01546-5.

Biospecimen

Retention: SAMPLES WITH DNA

Urine, and plasma

MeSH Terms

Conditions

SepsisInflammation

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jing Wang

    Yantai Yuhuangding Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations